PCOS(Insulin Resistant)PCOS HOMA IRNCT07472179
Effect of Pioglitazone vs Metformin on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS
A study testing Pioglitazone 30 Mg Oral Tablet and metformin 500 mg thrice daily in people with PCOS(Insulin Resistant), run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial summary
Women with PCOS with HOMA-IR >2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS(Insulin Resistant)
- What is being tested?
- Pioglitazone 30 Mg Oral Tablet and metformin 500 mg thrice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 12 Aug 2024to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed case of PCOS patients according to Rotterdam criteria
- HOMA-IR >2 (Hydrie et al., 2012)
- Age: 18-35 years
- BMI: 18.5 -27.5 kg/m²
Who cannot join
- Presence of any endocrine disorder (hyperthyroidism, hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, hyperprolactinaemia, diabetes mellitus).
- Presence of any medical comorbidity (renal, hepatic and cardiovascular disease)
- Any medication in the last three months which would affect insulin resistance (metformin, oral contraceptive pill)
- Any contraindications to Pioglitazone (Patients with a known hypersensitivity to pioglitazone or any of its components, Diabetic ketoacidosis or type 1 diabetes) or Metformin (severe chronic diseases e.g. hepatic, renal and cardiac failure or acute complications of diabetes e.g. ketoacidosis and hyperosmolar state).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pioglitazone on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS in Comparison to Metformin
Women with PCOS with HOMA-IR >2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months.
Read the detailed description
This study will be conducted in the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University from the day of IRB approval. Ethical clearance will be obtained from the Institutional Review Board. Selection of the patients will be done according to inclusion and exclusion criteria. Insulin resistant PCOS patients will be included only. The patients will be explained in details regarding the objectives, rationality and potential benefits of the study. The patients will be counseled regarding the drugs and unexpected side-effect and an informed written consent will be taken. Data will be collected through interview, physical examinations and laboratory investigations. All the data will be enrolled in the data sheet for this study. The random sequence generation of permuted block will be done by computer-generated random numbers. Eligible women will be randomized to either pioglitazone group (Group A) or metformin group (Group B).
Allocation concealment will be done using serially numbered closed opaque envelopes.
Each envelope will have a card inside noting the intervention drug. Allocation will not be changed after opening the closed envelopes.
Group A: Participants will receive Tab. Pioglitazone 30mg once daily for 12 weeks.
Group B: Participants will receive Tab. Metformin 500mg thrice daily for 12 weeks.
At first baseline height, weight, waist circumference and hip circumference will be measured and BMI and waist hip ratio will be calculated. Then baseline Fasting blood glucose, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done by collecting 5 ml blood from patient's anti cubital vein in 2nd day of menstruation and then HOMA-IR index and Free Androgen Index will be calculated. All participants will be instructed not to take any medications during the study except after consulting the physician. After 12 weeks of treatment, again BMI, waist circumference, hip circumference and waist hip ratio will be calculated and FBS, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done and HOMA-IR index and Free Androgen Index will be calculated. Clinical record form will be developed after pre-testing. The structured clinical record form (appendix I) will include domains like demographic data, eligibility checklist visit pages (baseline, 3 month follow up) \& adverse event log. The items will be demographic, clinical and laboratory variables. The form will be filled up by principal investigator. The cumulative data will be subjected to analysis.
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- Conditions
- PCOS(Insulin Resistant)
- Being tested
- Pioglitazone 30 Mg Oral Tablet, metformin 500 mg thrice daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 30 Mg Oral TabletDrug
pioglitazone 30 mg once daily for 3 months
metformin 500 mg thrice dailyDrug
tab. Metformin 500 mg given 3 times daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | pioglitazone 30 mg once daily Receives: Drug: Pioglitazone 30 Mg Oral Tablet; Drug: metformin 500 mg thrice daily |
| Comparator arm | Active comparator | metformin 500mg thrice daily for 3 months Receives: Drug: Pioglitazone 30 Mg Oral Tablet; Drug: metformin 500 mg thrice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical parameters of insulin resistant PCOS
Biochemical:
- HOMA-IR
Measured: baseline to 3 months
clinical parameter
waist hip ratio
Measured: 3 months
hormonal parameter
free androgen index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start12 Aug 2024
- Primary completion12 Dec 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCOS(Insulin Resistant)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label parallel design randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Medical University
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Farzana Deeba, MBBS,FCPS,MS,MRCOG, Study chair, Bangladesh Medical UniversityIsmat Jahan Kumkum, MBBS, Principal investigator, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472179
- Sponsor's protocol ID
- 5161
- Acronym
- PCOS HOMA IR
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sangeeta S. Metformin and pioglitazone in polycystic ovarian syndrome: a comparative study. J Obstet Gynaecol India. 2012 Oct;62(5):551-6. doi: 10.1007/s13224-012-0183-3. Epub 2012 Oct 16.
PubMed 24082557Zhao H, Zhang J, Xing C, Cheng X, He B. Metformin versus metformin plus pioglitazone on gonadal and metabolic profiles in normal-weight women with polycystic ovary syndrome: a single-center, open-labeled prospective randomized controlled trial. J Ovarian Res. 2024 Feb 19;17(1):42. doi: 10.1186/s13048-024-01367-7.
PubMed 38374053
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS in Comparison to Metformin
- ClinicalTrials.gov ID
- NCT07472179
- Acronym / sponsor ID
- PCOS HOMA IR / 5161
- Conditions
- PCOS(Insulin Resistant)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Collaborators
- Bangladesh Medical University
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with PCOS with HOMA-IR >2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months.
Detailed description
This study will be conducted in the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University from the day of IRB approval. Ethical clearance will be obtained from the Institutional Review Board. Selection of the patients will be done according to inclusion and exclusion criteria. Insulin resistant PCOS patients will be included only. The patients will be explained in details regarding the objectives, rationality and potential benefits of the study. The patients will be counseled regarding the drugs and unexpected side-effect and an informed written consent will be taken. Data will be collected through interview, physical examinations and laboratory investigations. All the data will be enrolled in the data sheet for this study. The random sequence generation of permuted block will be done by computer-generated random numbers. Eligible women will be randomized to either pioglitazone group (Group A) or metformin group (Group B).
Allocation concealment will be done using serially numbered closed opaque envelopes.
Each envelope will have a card inside noting the intervention drug. Allocation will not be changed after opening the closed envelopes.
Group A: Participants will receive Tab. Pioglitazone 30mg once daily for 12 weeks.
Group B: Participants will receive Tab. Metformin 500mg thrice daily for 12 weeks.
At first baseline height, weight, waist circumference and hip circumference will be measured and BMI and waist hip ratio will be calculated. Then baseline Fasting blood glucose, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done by collecting 5 ml blood from patient's anti cubital vein in 2nd day of menstruation and then HOMA-IR index and Free Androgen Index will be calculated. All participants will be instructed not to take any medications during the study except after consulting the physician. After 12 weeks of treatment, again BMI, waist circumference, hip circumference and waist hip ratio will be calculated and FBS, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done and HOMA-IR index and Free Androgen Index will be calculated. Clinical record form will be developed after pre-testing. The structured clinical record form (appendix I) will include domains like demographic data, eligibility checklist visit pages (baseline, 3 month follow up) \& adverse event log. The items will be demographic, clinical and laboratory variables. The form will be filled up by principal investigator. The cumulative data will be subjected to analysis.
--------------------------------------------------------------------------------
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label parallel design randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Pioglitazone 30 Mg Oral Tablet, Drug: metformin 500 mg thrice dailypioglitazone 30 mg once daily |
| Comparator arm | Active comparator | Drug: Pioglitazone 30 Mg Oral Tablet, Drug: metformin 500 mg thrice dailymetformin 500mg thrice daily for 3 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed case of PCOS patients according to Rotterdam criteria
- HOMA-IR >2 (Hydrie et al., 2012)
- Age: 18-35 years
- BMI: 18.5 -27.5 kg/m²
Key exclusion criteria (4 listed)
- Presence of any endocrine disorder (hyperthyroidism, hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, hyperprolactinaemia, diabetes mellitus).
- Presence of any medical comorbidity (renal, hepatic and cardiovascular disease)
- Any medication in the last three months which would affect insulin resistance (metformin, oral contraceptive pill)
- Any contraindications to Pioglitazone (Patients with a known hypersensitivity to pioglitazone or any of its components, Diabetic ketoacidosis or type 1 diabetes) or Metformin (severe chronic diseases e.g. hepatic, renal and cardiac failure or acute complications of diabetes e.g. ketoacidosis and hyperosmolar state).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone 30 Mg Oral Tabletpioglitazone 30 mg once daily for 3 months | Drug | Comparator arm, Experimental arm |
| metformin 500 mg thrice dailytab. Metformin 500 mg given 3 times daily for 3 months | Drug | Comparator arm, Experimental arm |
Primary outcome
biochemical parameters of insulin resistant PCOS
Time frame: baseline to 3 months
Biochemical: 1. HOMA-IR
clinical parameter
Time frame: 3 months
waist hip ratio
hormonal parameter
Time frame: 3 months
free androgen index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 24082557Sangeeta S. Metformin and pioglitazone in polycystic ovarian syndrome: a comparative study. J Obstet Gynaecol India. 2012 Oct;62(5):551-6. doi: 10.1007/s13224-012-0183-3. Epub 2012 Oct 16.
- Background: PubMed 38374053Zhao H, Zhang J, Xing C, Cheng X, He B. Metformin versus metformin plus pioglitazone on gonadal and metabolic profiles in normal-weight women with polycystic ovary syndrome: a single-center, open-labeled prospective randomized controlled trial. J Ovarian Res. 2024 Feb 19;17(1):42. doi: 10.1186/s13048-024-01367-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzana Deeba, MBBS,FCPS,MS,MRCOG study chair
Bangladesh Medical University
Ismat Jahan Kumkum, MBBS principal investigator
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone 30 Mg Oral Tablet and metformin 500 mg thrice daily in people with PCOS(Insulin Resistant), run by Mst.Sumyara Khatun at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical parameters of insulin resistant PCOS (time frame: baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07472179, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.